What does ISO 9001 mean? What is Quality System Certificate?

First, let’s briefly explain the concept of ISO. ISO is the coded abbreviation of the initials of the International Standards Organization. It is a formation that almost every country in the world is associated with and / or participates in:
ISO 9001 is just one of the tens of thousands of Standards published by this institution. ISO 9000 series standards are ‘volunteering’ based standards.
The ISO 9000:2015 Quality Management Standard, published by ISO, is a world standard. This standard has been translated into Turkish by TSE (Turkish Standards Institute), which is the authorized institution in this regard in our country.

What is Quality System Certificate?

Let us express the definition in the standard exactly: “It is the document given by the authorized organization in case the organizations operating in the manufacturing and service sectors establish their systems in accordance with TS EN ISO 9000 Quality Standards.

WHY does an institution take the decision to obtain ISO 9001 Certificate? What will ISO 9001 Certificate add to an institution?

Rather than obtaining the ISO 9001 certificate, the words acquiring, owning should be preferred.
For a business that has a history and aims to grow geometrically in the coming period, in the National and International arena, by taking the leap with expansions based on volume, scope, content, leadership and quality; With the guidance of ISO 9000 System Standard, it will be easier for organizations that have progressed towards institutionalization and are growing, to document existing applications, and to carry out development and improvement studies.

What will ISO 9001 Certificate add to an institution?

The Quality Management System Standard takes into account the current possibilities, predictions, expectations, orientations and needs of all employees and other parties who contribute to the realization of the product and / or service of the institution, from the Chairman of the Board of Directors to the security officer.

Who are the other parties?

Customers (first or second stage buyer of the Product and/or Service), Suppliers (Every person and institution that provides support, support), Stakeholders, in other words, senior management and the Environment.
Along with the physical environment, the legal legislation that determines the terms and limits of broadcasting is also included in the concept of environment. The Quality Management System aims to optimize the satisfaction of all the parties we count, and provides a framework infrastructure for this.

Can you summarize the Certification Process for an institution? What kind of Training is required?

After the decision to document is taken, a 2-stage ‘Activity Plan’, consisting of the main steps of Documentation Creation and Implementation, is prepared by meeting with the Unit Officers.
All personnel are informed about this with an announcement. Training begins. The Documentation to be prepared is submitted to the Certification Firm to be selected with the offers to be received.
After the document review and application inspection, the ISO 9000 Certificate and Flag is obtained by being deemed appropriate. Our goal is to wave this flag within the specified time.

What kind of Training is required?

In parallel with the ‘Training Plan’ prepared in the ongoing process, all personnel, starting from the executive staff, from experts and institutions in their fields, starting with ISO 9000 Basic Training, Documentation, Internal Inspection, Quality Concepts, Total Quality, Problem Solving Techniques, Technical and Vocational Trainings, Personal Training They will have received trainings on Development Trainings and similar issues, which will ensure that the Quality Management System is on a solid foundation, ensure the continuity of the system to be established, and increase individual quality.

What is the relationship or difference between Total Quality and ISO 9000 Quality Management System?

Total Quality Principles or Philosophy consists of the following sub-titles: Participation, Continuous Improvement / Development, Customer Orientation or Customer Satisfaction, Leadership, Solution partnership studies / sharing with suppliers, Continuity / Process Approach, Process Management / System Approach, Development, Data / Fact-based analysis and decision mechanism.
All these principles of TQM that we have mentioned are included in the 2000 revision of the Standard.

Can ISO 9000 bring with it some handicaps in terms of having binding aspects to an institution?

Contrarily!. The predictions and inquiries of the ISO 9001:2000 version of the standard will also bring a dynamism to the institutions. With the Continuous Development / Improvement and Communication article, positive potential elements that the business is perhaps not even aware of can be activated.
Stabilizing, binding, normative and status quo are overcome with the review article. Every item put in the system establishment is passed through the filters of ‘Creating Value Added’, ‘Applicability’, and ‘Defensibility’.
Our approach is whether all the steps in the living system and other determined factors will be included in the documentation and application model creation studies, and whether the findings will add value to the system / institution / employees, and most importantly, the audience who are the addressees of the service provided.
All the applications we model are constantly monitored with the key of performance and efficiency criteria to be determined. In the ongoing process, the continuity of the system is ensured by establishing the infrastructure for the continuous improvement of the processes based on objective measurement.
If we talk briefly about the application steps or in the prepared Documentation:
In fact, there is a system that has been running for years in every business. At this point, what we have done is to record, define and model the applications to be made with a coding system, almost all of the functions, units, forms and documents that are in practice and in use, leaving no gaps in all the points, conditions and needs or expectations of all relevant parties. One of the points to be reached at the end of the Certification Process is the establishment of the necessary infrastructure to ensure sustainability and continuity.
More to say!

We can give some clues from our own values, which will be included in the Quality Handbook of the institution, which will be included in the titles of Vision – Mission – Policy – Target… and so on:

  • Alcohol Report.
  • True Native,
  • Respecting Local Values,
  • Pioneer in the lane,
  • International and Continental Expansion and Sharing..

What is Sastek's main working area?

It is structured to provide Product – System – Service Certification – Calibration – Inspection services in the field of Sastek Measuring Instruments.

Which modules are used in CE marking application? Which module requires a Notified Body?

It has been divided into modules according to the risk factors of the products covered by the technical regulations created with the new approach policy used since 1990, and 8 modules from A to H have been created. These modules describe the procedures to be followed until the CE marking is attached to the product and are described in detail in the directives.

The modules listed from A to H are briefly described below.
Module A (Production Internal Control): In this module, which includes both the design and production phases, the manufacturer prepares the technical documents explaining the design, production and usage purposes of the product and the CE declaration of conformity and attaches the CE mark to the product. This module does not require the intervention of the notified body.
Module B (EU Type Examination): This module, which only covers the design phase, is not usually used alone. It is used with C, D, E and F modules. The manufacturer delivers the product-related documents and, if possible, the prototype to the notified body. The notified body tests the conformity of the product with the essential requirements, or has it made and issues the Type Examination Certificate.
Module C (Declaration of Conformity to Type): This module, which is for the production phase, is used together with the B module. The manufacturer declares and guarantees that the product will be produced in accordance with the type described in the EU type examination certificate. In this module, some technical regulations may require random product checks to be carried out by a notified body or under the responsibility of a notified body.
Module D (Production Quality Assurance): It covers the production phase and follows the B module. It envisages the establishment of a quality assurance system that includes production, plant and service stages (former ISO 9002). Tests related to the basic requirements of the product are carried out by the notified body.
Module E (Product Quality Assurance): It covers the production phase and follows the B module. It provides for the establishment of a quality assurance system that includes final inspection and testing (former ISO 9003). The manufacturer performs the tests and experiments of the final product within the framework of the quality system.
Module F (Product Verification): This module for the production phase is used together with module B. A CE mark is attached to the product with the written certificate of conformity within the framework of this module, in which a notified body checks the conformity of the product to the technical documents and the definitions in the type examination.
Module G (Unit Verification): This module, which covers both the design and production stages, is generally used for custom-made or small-scale serial production. The manufacturer prepares a technical file that includes the design and production stages of the product.
The notified body carries out the necessary examinations to determine the conformity of the product with the requirements specified in the technical regulations. The manufacturer prepares the written declaration of conformity and affixes the CE marking.
Module H (Full Quality Assurance): < each Manufacturer provides a written declaration of conformity and affixes the mark E C to the product. The system of technical related products in the regulations specified in the requirements, the conformity of which must be approved by the quality assurance. It should cover the module according to the production, design, manufacturer, service, stages that include ISO 9001, which describes the facility system as a quality system.
Assurance of the system, which envisages the implementation of the manufacturing design module H together with the stages > Module H, which envisages the implementation of the full quality assurance system, covers the design and manufacturing stages together.
According to the module, the manufacturer must establish and certify a quality assurance system (as defined in ISO 9001) that includes the stages of design, production, installation and service. The quality assurance system ensures that the products comply with the requirements specified in the relevant technical regulations. The manufacturer affixes the C E marking to each product and draws up a written declaration of conformity.

What is a Notified Body?

It has been divided into modules according to the risk factors of the products covered by the technical regulations created with the new approach policy used since 1990, and 8 modules from A to H have been created. These modules describe the procedures to be followed until the CE marking is attached to the product and are described in detail in the directives.

The modules listed from A to H are briefly described below.
Module A (Production Internal Control): In this module, which includes both the design and production phases, the manufacturer prepares the technical documents explaining the design, production and usage purposes of the product and the CE declaration of conformity and attaches the CE mark to the product. This module does not require the intervention of the notified body.
Module B (EU Type Examination): This module, which only covers the design phase, is not usually used alone. It is used with C, D, E and F modules. The manufacturer delivers the product-related documents and, if possible, the prototype to the notified body. The notified body tests the conformity of the product with the essential requirements, or has it made and issues the Type Examination Certificate.
Module C (Declaration of Conformity to Type): This module, which is for the production phase, is used together with the B module. The manufacturer declares and guarantees that the product will be produced in accordance with the type described in the EU type examination certificate. In this module, some technical regulations may require random product checks to be carried out by a notified body or under the responsibility of a notified body.
Module D (Production Quality Assurance): It covers the production phase and follows the B module. It envisages the establishment of a quality assurance system that includes production, plant and service stages (former ISO 9002). Tests related to the basic requirements of the product are carried out by the notified body.
Module E (Product Quality Assurance): It covers the production phase and follows the B module. It provides for the establishment of a quality assurance system that includes final inspection and testing (former ISO 9003). The manufacturer performs the tests and experiments of the final product within the framework of the quality system.
Module F (Product Verification): This module for the production phase is used together with module B. A CE mark is attached to the product with the written certificate of conformity within the framework of this module, in which a notified body checks the conformity of the product to the technical documents and the definitions in the type examination.
Module G (Unit Verification): This module, which covers both the design and production stages, is generally used for custom-made or small-scale serial production. The manufacturer prepares a technical file that includes the design and production stages of the product.
The notified body carries out the necessary examinations to determine the conformity of the product with the requirements specified in the technical regulations. The manufacturer prepares the written declaration of conformity and affixes the CE marking.
Module H (Full Quality Assurance): < each Manufacturer provides a written declaration of conformity and affixes the mark E C to the product. The system of technical related products in the regulations specified in the requirements, the conformity of which must be approved by the quality assurance. It should cover the module according to the production, design, manufacturer, service, stages that include ISO 9001, which describes the facility system as a quality system.
Assurance of the system, which envisages the implementation of the manufacturing design module H together with the stages > Module H, which envisages the implementation of the full quality assurance system, covers the design and manufacturing stages together.
According to the module, the manufacturer must establish and certify a quality assurance system (as defined in ISO 9001) that includes the stages of design, production, installation and service. The quality assurance system ensures that the products comply with the requirements specified in the relevant technical regulations. The manufacturer affixes the C E marking to each product and draws up a written declaration of conformity.

How is the CE mark attached to the product?

Products within the scope of New Approach Directives are evaluated in two groups as “Low-risk products” and “High-risk products”. In the relevant directives, it is stated which group the products fall into.
For low-risk products, the manufacturer determines whether the product complies with the relevant directive and, if appropriate, can affix the CE marking to the product by issuing a declaration of conformity. Here, the manufacturer determines the conformity of the product by taking into account the directive or has the product tested by another testing institution.
For high-risk products, the manufacturer is absolutely obliged to apply to “Notified Bodies”. The conformity of the product with the relevant directives is determined as a result of the test to be carried out by the “Notified Body”, that is, the test and/or certification body applied for. Based on this determination, the manufacturer can affix the CE mark to the product by issuing a declaration of conformity.

Why is the CE mark important?

The CE mark functions as a kind of passport for the products to be released for free circulation in EU member states.
Since Turkey will harmonize and implement the European Union legislation, with the entry into force of the relevant legislation, it becomes obligatory for the products to be supplied to the market in our country to bear this mark.

What is the CE mark?

The CE mark is a conformity mark showing that the product has minimum safety requirements. This mark is not related to quality assurance.
The product it is on; It is a sign that represents no risk from human, environmental and animal health and plant life vaccine. CE abbreviation consisting of the first letters of the words ‘Conformity Europen’; It means European Conformity.